Last synced on 25 April 2025 at 11:05 pm

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210083
510(k) Type
Special
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2021
Days to Decision
28 days
Submission Type
Summary

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210083
510(k) Type
Special
Applicant
Penumbra, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2021
Days to Decision
28 days
Submission Type
Summary